68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

Vanderbilt University Medical Center

Status and phase

Completed

Phase 2

Conditions

Neuroendocrine Carcinoma

Treatments

Radiation: 68Ga-DOTATATE PET scan

Study type

Interventional

Funder types

Other

Identifiers

NCT01396382

110588 (Other Identifier)

VICC GI 1136

Details and patient eligibility

About

Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. The investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.

Full description

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 68GaDOTATATE and undergo a PET/CT imaging study. Scans will be performed with "negative" oral contrast (e.g. Volumen™ or equivalent), as many NETs involve the GI tract.

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Known diagnosis of neuroendocrine tumor
At least 18 years of age
Able to provide informed consent
Karnofsky score greater than 50
Females of childbearing potential must have a negative pregnancy test at screening/baseline

Exclusion criteria

Serum creatinine >3.0 mg/dL (270 μM/L)
Hepatic enzyme levels more than 5 times upper limit of normal.
Known severe allergy or hypersensitivity to IV radiographic contrast.
Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Recognized concurrent active infection
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.